Age-matched Reference Values for Circulating Natural Killer T-like Cells (NKT)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Healthy

Treatments: Diagnostic Test: Lymphocyte Immunophenotyping Test

Study type: Interventional

Funder types: Other

Identifiers

NCT06450743

0014476

Details and patient eligibility

About

Few data are so far available regarding the adult normal values of circulating NKT-like cell concentration, and none for the pediatric population. The primary objective of this study is to determine the reference values for NKT-like cells in pediatric and adult patients (derivation cohort). The secondary objective is to validate the results obtained from the adult derivation cohort with those obtained from an adult validation cohort, consisting of a group of healthy adult volunteers.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy blood donor
• without acute or chronic pathological conditions
• matched for sex and age with the retrospective adult derivation cohort

Exclusion criteria

• a history of immunological or hematological diseases, immunosuppressive or immunostimulant therapies, or ongoing infections
• one of the lymphocyte subpopulations tested out of range
• undergoing surgery or dentistry intervention in the past two months

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Derivation Cohort

Other group

Description:

Adult and pediatric patients who have routinely performed the lymphocyte immunophenotyping test, including also the enumeration of NKT-like cells, to exclude an immunological impairment during the period from May 2019 to March 2020 (for adults) and from May 2019 to August 2021 (for pediatric patients).

Treatment:

Diagnostic Test: Lymphocyte Immunophenotyping Test

Validation Cohort

Other group

Description:

Healthy adult blood donors in order to validate the obtained results.

Treatment:

Diagnostic Test: Lymphocyte Immunophenotyping Test